Non-compliance is generally associated with patients having chronic illness or illnesses such as hypertension, diabetes, psychotics, hypercholesterolemia etc. The reasons for non compliance are many which include multiple medication administration, complex treatment regimens, frequent dose regimens, increasing numbers of medication prescribed and the increase in side effects and/or drug interactions associated with multiple drug regimens.
Studies have reported that non compliance increases when the number of tablets or capsules taken daily increases from one to four times daily (Galley, M. S. To be taken as directed. JIR Coll Gen Pract, 1968, 16, 39-44. Eisen, S. A. et al., Arch Intern Med 150, p. 1881, 1990. “The administration of medication at frequent intervals makes it more likely that the patient's normal routine or work schedule will have to be interrupted to take a dose of medication and in many cases the patient will forget, not want to be inconvenienced or be embarrassed to do so.” Remington's Pharmaceutical Sciences, Chpt. 103, Vol. II, p. 1800 (19th Ed. 1995).
The Physician's and pharmacist's relationship with the patient will influence medication compliance. For example, how clearly the physician and/or pharmacist explain the treatment regimen to the patient being treated will influence how likely the patient will comply with the drug therapy prescribed.
Medication compliance aids have been developed to enhance compliance. In medicine, compliance (also adherence, concordance, or capacitance) describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but may also mean use of medical appliances such as compression stockings, chronic wound care, self-directed physiotherapy exercises, or attending counseling or other courses of therapy. One example is a compliance package. A compliance package may be defined as “a prepackaged unit that provides one treatment cycle of the medication to the patient in a ready-to-use package”
U.S. Pat. No. 7,328,802 provides a child resistant blister packages utilizing walled structures enclosing medicament therein.
US Application No. 20080190801 relates to pharmaceutical packaging systems or improved patience compliance.
US Application No. 20070093497 relates to methotrexate compliance package.
WO98/22072 relates to compliance package and method of improving or aiding patient compliance for complex drug regimens.
Some of the prior art compliance packages are; For example, OvconX 35 and 50 (Bristol-Meyers Squibb), Ortho-Novum Dialpak 1/35, 1/50, 10/11 and 7/7/7 (Ortho Pharmaceutical Corp.), Loestrin (D Fe 1/20 and 1.5/30 (Parke-Davis), etc. are oral contraceptives packaged in blister cards. These packages are generally a single blister card, with 21 or 28 day regimens; RheumatrexQ) Dose Packs made by Lederle Laboratories, containing four blister-pack cards each containing either 2, 3, 4, 5, or 6 tablets (for 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per week, respectively) for 1-week's therapy of methotrexate; Medrol Dosepak (Upjohn Company), is a packaging designed for the administration of steroids, (i.e. methylprednisolone) which require staggered dosing. For each day of drug treatment the number of tablets (and total dose) that the patient must take, decreases. For example, the Medrol Dosepak contains 21, 4 mg tablets for 6 days of treatment where for each day of treatment, the total daily dose decreases by one tablet; ZithromaxX Z-Pak made by Pfizer Laboratories, contains a single medication blister card with 6, 250 mg capsules. Each blister medication card is labeled with “Day 1 to Day 5” for each dose, the first dose being two, 250 mg capsules labeled “Day 1.” Each subsequent capsule is labeled with “Day 2” to “Day 5.”